{"id":1225,"date":"2022-03-15T17:09:37","date_gmt":"2022-03-15T09:09:37","guid":{"rendered":"https:\/\/regask.com\/?p=1225"},"modified":"2024-11-22T05:29:31","modified_gmt":"2024-11-21T21:29:31","slug":"evidencia-del-mundo-real-sobre-afirmaciones-de-venta-libre","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/real-world-evidence-otc-claims\/","title":{"rendered":"C\u00f3mo la evidencia del mundo real respald\u00f3 la fundamentaci\u00f3n de las afirmaciones..."},"content":{"rendered":"<p>Un l\u00edder de la industria farmac\u00e9utica quer\u00eda aprovechar evidencia del mundo real para reforzar las afirmaciones de un producto de venta libre (OTC) en los mercados de la UE y EE. UU.<\/p>\n<p>De hecho, a medida que los investigadores recopilan evidencia del mundo real, pueden examinar variables que antes no se hab\u00edan tenido en cuenta en las primeras fases de los ensayos, como fumar y beber, lo que les permite obtener una comprensi\u00f3n m\u00e1s profunda de c\u00f3mo esos factores afectan el producto del estudio.<\/p>\n<p>El cliente, al reconocer el surgimiento de pautas sobre el uso adecuado de evidencia del mundo real para respaldar afirmaciones en ambos mercados, quer\u00eda garantizar su cumplimiento de la nueva regulaci\u00f3n al usar la evidencia para fundamentar las afirmaciones de sus productos.<\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">\u00bfQu\u00e9 es? <strong>Problema<\/strong>?<\/h2>\n<p>El cliente necesitaba obtener una descripci\u00f3n general de las regulaciones relacionadas con el uso de evidencia del mundo real.<\/p>\n<ul>\n<li>Evaluar la viabilidad y los requisitos para fundamentar una reclamaci\u00f3n particular.<\/li>\n<li>Fomentar una mayor comprensi\u00f3n de los requisitos relevantes<\/li>\n<li>Y adherirse a nuevas pautas regulatorias sobre el uso de evidencia del mundo real para fundamentar nuevas afirmaciones o fortalecer indicaciones existentes.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">Lo que nosotros <strong>Hizo<\/strong>\u2026<\/h2>\n<p>RegASK propuso una soluci\u00f3n de respuesta r\u00e1pida aprovechando su red global de expertos regulatorios y tecnolog\u00eda automatizada patentada, y<\/p>\n<ul>\n<li>Requisitos identificados en los mercados de la UE y EE. UU.<\/li>\n<li>Se evaluaron las afirmaciones deseadas para estimar la probabilidad de fundamentaci\u00f3n mediante evidencia del mundo real.<\/li>\n<li>Y recomend\u00f3 una estrategia con visi\u00f3n de futuro para cada mercado.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">\u00bfC\u00f3mo lo hizo? <strong>Hacer<\/strong>?<\/h2>\n<p>RegASK proporcion\u00f3 una descripci\u00f3n regulatoria clara de la fundamentaci\u00f3n de reclamos en el mundo real en menos de tres semanas.<\/p>\n<p>El cliente pudo tomar decisiones apropiadas y eficientes con la fundamentaci\u00f3n de su reclamaci\u00f3n y\u00a0<strong>Identificar una estrategia s\u00f3lida de ensayos cl\u00ednicos en los mercados de la UE y EE.UU.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\"><strong>Conclusi\u00f3n<\/strong><\/h2>\n<p>Nuestro cliente necesitaba ayuda con el\u00a0<a href=\"https:\/\/regask.com\/es\/our-solution\/\"><strong>Justificaci\u00f3n de la reclamaci\u00f3n de uno de sus productos OTC mediante evidencia del mundo real<\/strong><\/a>\u00a0y el\u00a0<strong>Validaci\u00f3n de una estrategia de ensayo cl\u00ednico<\/strong>.<\/p>\n<p>El esfuerzo de nuestros expertos regulatorios, combinado con nuestra tecnolog\u00eda automatizada patentada, nos permiti\u00f3 entregarlos en menos de tres semanas.\u00a0<strong>Toda la informaci\u00f3n regulatoria sobre la fundamentaci\u00f3n de reclamaciones con evidencia del mundo real\u00a0<\/strong>Necesitaban decidir c\u00f3mo abordar la elecci\u00f3n de una estrategia cl\u00ednica s\u00f3lida.<\/p>\n<a data-animate=\"fadeInUp\" href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" >\n\t\t<span>Obtenga una cotizaci\u00f3n<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>A leader in the pharmaceutical industry wanted to leverage real-world evidence to bolster the claims of an over the counter (OTC) product in the E.U. and U.S. markets. Indeed, as researchers collect real-world evidence, they can examine variables previously unaccounted for in early trial phases such as smoking and drinking, allowing them to gain a&#8230;<\/p>","protected":false},"author":39,"featured_media":1813,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,21],"tags":[],"class_list":["post-1225","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-pharma-and-biotech"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Real-World Evidence for OTC Claims | RegASK<\/title>\n<meta name=\"description\" content=\"Learn how real-world evidence supports claim substantiation for OTC products in Europe and the USA with RegASK.\" \/>\n<meta name=\"robots\" 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